Trokamed GmbH FDA Recalls

4 recalls on file across devices, 4 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.Class INov 27, 2024If the inflow speed is too quick, it could result in reduced	If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fr	Class IDevices	Nov 27, 2024
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.Class INov 27, 2024If the inflow speed is too quick, it could result in reduced	If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fr	Class IDevices	Nov 27, 2024
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.Class INov 27, 2024If the inflow speed is too quick, it could result in reduced	If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fr	Class IDevices	Nov 27, 2024
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.Class INov 27, 2024If the inflow speed is too quick, it could result in reduced	If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fr	Class IDevices	Nov 27, 2024